Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal
In the order, the District Judge found that Catalyst’s interpretation of the Orphan Drug Act “is not necessarily wrong, but it is not the only reasonable way to interpret the plain language of the statute.” The District Judge found that the relevant statutory language was ambiguous and adopted FDA’s interpretation rather than Catalyst’s. The District Judge also rejected Catalyst’s argument that the approved labeling for Ruzurgi® is false and misleading. As a result of the District Judge's decision, Ruzurgi® remains approved for the treatment of pediatric LEMS patients in the United States.
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst can successfully overturn the decision of the District Judge in the 11th Circuit Court of Appeals, (ii) whether Catalyst can continue to successfully market its product despite the lower price charged by Jacobus for its amifampridine drug, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.